Cytiva_APR21_EarlyProcessDevDecisions - 8

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

The role of CDMOs in Cell and Gene
Therapy Process Development
Scale-up, tech transfer, assay development, and other
areas where they can help.

F

or developers of cell and gene therapies

(CDMOs). In this article, we highlight key areas

(CGT), translating a drug from a biological

where CDMOs can help companies get started

concept to a scalable and manufactur-

in the world of CGT manufacturing. We also

able treatment can be the largest challenge in

discuss when to engage with CDMOs to maximize

achieving commercial success. This is especially

commercial and clinical success.

difficult in the CGT field, because there is a limited
number of qualified personnel with both biolog-

CELL SOURCE CONSIDERATIONS

ical and process engineering know-how. Other

CGT products start with either primary or

challenges are evolving regulatory constraints

modified cell lines as the cell source. Drug devel-

and aggressive timelines from investors.

opers often choose primary cell lines when

Even for experienced teams, it can be tricky to

dosing requirements and patient numbers are

balance the efforts of reaching the first clinical

low or when personalized, autologous therapies

trial using a manual, open method with building

are produced. They typically select modified

a more commercially suitable process. To accel-

cell lines when larger patient populations are

erate their clinical and commercial programs,

targeted or where the cells are being used as

companies are choosing to work with contract

a producer line for secreted products, such as

development and manufacturing organizations

exosomes or viral vectors. Each cell source has a

Emerging biotech accelerator
Access process development and
biomanufacturing support for
early-stage biotech.

8|

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Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Cover1
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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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